[Federal Register Volume 59, Number 213 (Friday, November 4, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-27269]


[[Page Unknown]]

[Federal Register: November 4, 1994]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Public Health Service

 

Agency Forms Submitted to the Office of Management and Budget for 
Clearance

    Each Friday the Public Health Service (PHS) publishes a list of 
information collection requests it has submitted to the Office of 
Management and Budget (OMB) for clearance in compliance with the 
Paperwork Reduction Act (44 U.S.C. Chapter 35). The following requests 
have been submitted to OMB since the list was last published on Friday, 
October 21, 1994.
    (Call PHS Reports Clearance Officer on 202-690-7100 for copies of 
request).
    1. MEDWATCH: FDA's Medical Product Reporting Program--0910-0291 
(Extension, no change)--This form is used for reporting adverse events 
and product problems with medications, devices, and other products 
(such as dietary supplements) that are regulated by the agency. 
Respondents: Businesses or other for-profit, small businesses or 
organizations; Number of Respondents: 83,694; Number of Responses per 
Respondent: 3.8; Average Burden per Response: .93 hour; Estimated 
Annual Burden: 296,719 hours.
    2. Application for Participation in the Indian Health Service 
Scholarship Program--0917-0006 (Reinstatement)--The information to be 
collected will be used to select the Indian Health Service pregraduate, 
preparatory, and/or health professions scholarship grantees and to 
monitor progress of award. Respondents: Individuals or households, 
State or local governments, businesses or other for-profit, non-profit 
institutions, small businesses or organizations; Number of Respondents: 
11,730; Number of Responses per Respondent: 1; Average Burden per 
Response: .46 hours; Estimated Annual Burden: 5,395 hours.
    3. Community Health Center User and Visit Survey--New--A two-part 
study will be conducted of Community Health Centers (CHCs) funded under 
Section 330 of the PHS Act. Personal interviews with CHC users will 
provide information on health status, utilization of and satisfaction 
with services, and sources of care. Data will also be abstracted from 
medical records for a sample of visits. Respondents: Individuals or 
households, Non-profit institutions.

                                                                        
------------------------------------------------------------------------
                                                         Average burden 
       Title             No. of       No. of responses    per response  
                       respondents     per respondent        (hours)    
------------------------------------------------------------------------
User survey.......             2,000                 1                 2
Medical visit                                                           
 abstraction......                50                 1                30
CHC induction                                                           
 interview........                50                 1                 3
------------------------------------------------------------------------
Estimated Total Annual Burden....5,650 hours.                           

    4. Transmittal of Periodic Reports and Promotional Material for New 
Animal Drugs--0910-0019 (Reinstatement)--These records and reports are 
used to facilitate a determination as to whether there may be grounds 
for suspending or withdrawing approval of the application, or whether 
any applicable regulation should be amended or repealed. The 
respondents are the sponsors of approved New Animal Drugs Applications 
whose numbers have increased over the years. Respondents: Businesses or 
other for-profit.

                                                                        
------------------------------------------------------------------------
                                                         Average burden 
      Title              No. of       No. of responses    per response  
                      respondents      per respondent        (hours)    
------------------------------------------------------------------------
Reporting, 21 CFR                                                       
 510.302(a).......             1,500               2.3                .5
Recordkeeping, 21                                                       
 CFR 510.300(a)...             1,500                 1             10.35
------------------------------------------------------------------------
Estimated Total Annual Burden ... 17,275 hours.                         

    Written comments and recommendations concerning the proposed 
information collections should be sent within 30 days of this notice 
directly to the OMB Desk Officer designated below at the following 
address: Shannah Koss, Human Resources and Housing Branch, New 
Executive Office Building, room 10235, Washington, DC 20503.

    Dated: October 27, 1994.
James Scanlon,
Director, Division of Data Policy, Office of Health Planning and 
Evaluation.
[FR Doc. 94-27269 Filed 11-3-94; 8:45 am]
BILLING CODE 4160-17-M